Patent attorney Monte Falcoff recently spoke to Medtech Insight on the topic of digital health innovations and electromechanical medical device patent applications in a post-Alice world. The issue at hand is whether these new products, which rely heavily on software more than hardware, are eligible to be patented in the challenging legal landscape imposed by the Supreme Court’s Alice decision.

The case in question, Alice Corp. v. CLS Bank International, was decided at the U.S. Supreme Court in 2014. The case is notable for raising the issue of what can and cannot be patented — namely software — under the 35 U.S.C. §101 topic of “patentable subject matter.”

By way of background, the U.S. Supreme Court relied on another case, Mayo v. Prometheus. The Mayo case found medical diagnostic method claims to be unpatentable because they relied on optimization of therapeutic efficacy including administering a thiopurine drug in the treatment of autoimmune diseases, and determining the level of metabolites, such that Prometheus had patented a “natural law” that would block all use of the correlations between the naturally-produced metabolites, and therapeutic efficacy and toxicity.

The Alice court then developed a two-step process for determining what would be patentable and what would be deemed an “abstract idea” and therefore unpatentable.

Patent eligible subject matter has generally been defined as any new, non-obvious and useful process, machine, material composition, or method of manufacturing, or any useful improvement thereof. The Mayo and Alice rulings, however, firmly pushed the pendulum regarding laws of nature, natural phenomena and abstract ideas toward being expressly unpatentable with regard to medical diagnostic devices and software.

“That’s a very loaded sentence,” said Falcoff. “Especially with the abstract ideas portion, that’s where all the controversy is right now.”

Under Alice, anything with the look or smell of abstraction can invoke the dreaded two-step process — a major problem for companies investing considerable money and R&D efforts into new technology only to have them invalidated at the final stage. These subjective rulings can be especially frustrating for the medical field, where innovations generally have to pass numerous regulations from other government organizations, and where true inventions and improvements can bring success to companies and benefits to patients.

Falcoff acknowledges that patents with method claims can have an even harder time. Method claims, which describe a method of making or using a machine, are more likely to be applied to software innovations. “In today’s world of big data analytics … it’s really the software and algorithms doing the work, but patents are being rejected,” he says.

For medical device companies looking to overcome the hurdles put in place by Alice, Falcoff offers four strategies to consider:

Provide as much detail about the hardware and electrical circuit as possible in a new patent application, even if the hardware isn’t the point of novelty

Talk to patent examiners on the phone or in person, as they often have helpful suggestions to overcome invalidity issues

Include multiple, differently written independent claims, including claims focused on the hardware and some that work in the software

If a patent is rejected and there are no previous prior art rejections, appeal to the United States Patent and Trademark Office, since more patentee-friendly court decisions have been issuing over the past year or two

While the case law has followed a strange and subjective path, there are signs that the pendulum is swinging back toward the allowance of more software patents. Businesses and patent attorneys would do well to follow these cases closely and keep an eye on what is allowed and what is rejected.